Warwick Clinical Trials Unit: Emergency and Critical Care Research www.warwick.ac.uk/go/ctu Selected Publications Overview Selected Publications Nakash RA, Lamb SE, Fisher J, Gates S, Hutton JL (2008) Response & nonresponse to postal questionnaires in a clinical trial - a qualitative study of the patient's perspective, Journal of Evaluation in Clinical Practice, 14(2) 226-35. Warwick Clinical Trials Unit is an academic unit undertaking clinical trials addressing real issues of local, national and international importance. Lamb SE, Marsh JL, Hutton JL, Nakash R, Cooke MW (2009) Mechanical supports for acute, severe ankle sprain. A multi-centre randomised controlled trial, Lancet , 373, 575-581 We lead or support the development of high quality randomised controlled trials in selective, focused areas that are consistent with the research strategy of Warwick Medical School, and in which the University of Warwick has a key stake in the intellectual property. Cooke MW, Nakash R, Jarvis RM, Szczepura A, Clarke M, Hutton JA, Marsh J, Lamb SE on behalf of the CAST (2007) A randomised controlled trial of mechanical supports for the management of severe ankle sprains in the emergency department, Health Technology Assessment OSCAR High Frequency OSCillation in ARDS •This trial is a multi-centre, randomised controlled trial funded by the Health Technology Assessment programme and sponsored by the University of Oxford •It compares high frequency oscillatory ventilation (HFOV) with conventional ventilator for adults with acute respiratory distress syndrome •Data collected on patients: (a) in intensive care units (ICU) (b) through to hospital discharge (c) at follow-up at 6 and 12 months after randomisation •Primary outcome: Mortality at 30 days after randomisation •Secondary outcomes: ICU, hospital discharge and follow-up data, as well as an economic evaluation •The total sample size required is 1006 patients •The trial has currently recruited 132 patients in 12 ICUs Our main research themes include Emergency and Critical Care, Rehabilitation, Cancer, and Methodology. This poster provides an overview of our Emergency and Critical Care research. BALTI-2 BALTI-2 (Beta Agonist Lung Injury Trial 2) •This is a large scale multi-centre clinical trial funded by the UK Medical Research Council (MRC). •Patients with Acute respiratory distress syndrome (ARDS) are randomised to receive IV infusion of Salbutamol or placebo for 7 days (maximum). •Survivors are followed by at 1 year. •Primary outcome: mortality at 28 days after randomisation •Secondary outcomes: mortality (at 1 year), quality of life (at 1 year), hospital and ICU length of stay, adverse events, health economic evaluation. •1, 334 patients recruited from 50 intensive care units (ICUs) •Trial started in September 2008 and currently has recruited 82 patients from 15 participating ICUs Lamb SE, Gates S, Underwood MJ, Cooke MW, et al (2007) Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders, BMC Musculoskeletal Disorders; 8:7. PMID: 17257408 Williamson E, Williams M, Gates S, Lamb SE (2007) A systematic literature review of psychological factors and the development of Late Whiplash Syndrome, Pain; Pain. 2008 Mar;135(1-2):20-30. Williams M, Williamson E, Gates S, Lamb S (2007) A systematic literature review of physical prognostic factors for the development of Late Whiplash Syndrome, Spine 32; (25): E764-780 MINT MINT Trial (Managing Injuries of the Neck Trial) • A multi-centre randomised controlled trial funded by the NIHR Health Technology Assessment Programme. • Primary aim : to estimate the clinical and cost effectiveness of a stepped care approach for whiplash injuries •Two stages to the trial: Stage 1: Cluster randomised trial, where NHS Emergency Departments (ED) were randomised to either a Whiplash Book or usual advice Stage 2: Patient still experiencing problems approx. 3 weeks after their initial neck injury were randomised to either physiotherapy or a single advice session (reenforcing the advice given in AD department) •3533 patients recruited to Stage 1; 599 patients recruited to Stage 2 •Patients followed–up at 12 months. CAST Collaborative Ankle Support Trial (CAST) •This trial was a multi-centre randomised trial funded by the UK Department of Health through its Health and Technology Assessment Programme •It estimated the clinical and cost effectiveness of three different methods of mechanical support (below knee cast, an Aircast brace and Bledsoe boot) compared with Tubigrip in the treatment of severe ankle sprains •600 patients were randomised to one of the four treatment groups and followed up at 1, 3 and 9 months after injury. •Primary outcome : return to function (Foot and Ankle Outcome Score questionnaire) •Results: At 1 month, knee cast gave the best results and by 9 months there was no difference in the treatments. Knee cast was the most cost effective •The study suggests that choice of treatment may affect speed of recovery but not long-term outcome. •Trial has finished- results are currently under review. Contact Dr Ranjit Lall (02476 574649) r.lall@warwick.ac.uk POSTER TEMPL ATE BY: www.PosterPresentations.com Contact Dr Simon Gates (02476 575850) S.Gates@warwick.ac.uk Contact Contact Mark Williams (02476 574648) M.A.Williams.3@warwick.ac.uk Professor Sallie Lamb (02476 574658) S.Lamb@warwick.ac.uk